Regulatory Open Forum

 View Only

  • 1.  Timing of Self-identification and GDUFA Fees

    Posted 21-Apr-2014 19:03
    We are preparing to manufacture a generic for a client.  To date we have manufactured generic non-GMP and clinical material for bio-equivalency/bio-availability studies.  No commercial manufacturing has occurred and ANDA(s) have not been submitted.

    When will we be responsible to self-identify as a generic manufacturer and pay the associated GDUFA fees?  Are we responsible for filing during the current reporting period, ending April 30, 2014?

    -------------------------------------------
    Charles P Van Beveren, PhD, RAC
    San Diego CA
    United States
    -------------------------------------------


  • 2.  RE:Timing of Self-identification and GDUFA Fees

    Posted 22-Apr-2014 09:06
    There are a few links on FDA.gov that I hope you find helpful.  This link (Generic Drug User Fees) contains further links to other documents including this FAQ.  There is also a Technical Walk-Through and Live Question and Answer Session and an Overview and Technical Walk-Through of Self-Identification Process (archived webcast).

    I don't see an obvious answer to when to submit for manufacturers just beginning, although it may be in one of the "Walk-throughs."  Most Q&A assume the manufacturer has already been in business and just pays every October 1.  For assistance in understanding when a GDUFA Cover Sheet is required, please contact FDA's Division of Drug Information at 866-405-5367 or 301-796-6707 or AskGDUFA@fda.hhs.go.

    To submit your self-identification file to the FDA, you must first obtain a WebTrader account with the FDA Electronic Submission Gateway (ESG).  See Setting up a WebTrader Account Checklist.

    Good luck.

    -------------------------------------------
    Andrea Chamblee RAC, FRAPS
    FDA
    Silver Spring MD
    United States
    -------------------------------------------






    Original Message


  • 3.  RE:Timing of Self-identification and GDUFA Fees

    Posted 22-Apr-2014 11:01
    Charles,

    Based on your description (for example, non-GMP, no ANDA submission), you don't seem to fall under five categories set out under GDUFA 2012 and Title III of FDASIA 2012.  Please read the statutes and FDA guidance below.

    http://www.fdaguidance.net/gdufa-self-identification-of-generic-drug-facilities-sites-and-organizations/

    You can always call FDA to inquire further...


    -------------------------------------------
    http://www.regulatorydoctor.com
    Riner VA
    United States
    -------------------------------------------






    Original Message


  • 4.  RE:Timing of Self-identification and GDUFA Fees

    Posted 23-Apr-2014 17:25
    Charles,
    Not sure I understood your question. Is the new generic drug you are preparing to manufacture an FDA approved drug for commercial distribution? If you answer is yes,  then you will need to identify as a generic manufacturer before you initiate manufacturing. Your client will have to add you to their NDA and you will also have to obtain FDA approval to manufacture drug products for commercial distribution.
    -------------------------------------------
    Elvira Marquez
    San Diego CA
    United States
    -------------------------------------------






    Original Message